BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KODAK DIRECTVIEW DR 9000 SYSTEM

    MDR report key: 929971 · Received April 4, 2007

    Report

    Report Number
    1317307-2007-00001
    Event Type
    Malfunction
    Date Received
    April 4, 2007
    Date of Event
    March 16, 2007
    Report Date
    April 4, 2007
    Manufacturer
    EASTMAN KODAK COMPANY
    Product Code
    MQB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INITIAL INVESTIGATION, KODAK FOUND THROUGH EQUIPMENT ERROR LOG THAT THERE APPEARED TO BE A LOSS OF COMMUNICATION BETWEEN THE KODAK DIRECTVIEW DR 9000 SYSTEM DETECTOR ARRAY CONTROLLER (DRAC) AND THE OPERATOR CONSOLE. KODAK HAS REPLACED THE DETECTOR ARRAY CONTROLLER WITH A NEW ONE. KODAK HAS INSTRUCTED THE CUSTOMER TO REBOOT DR 9000 SYSTEM DAILY, IF POSSIBLE, AND WEEKLY AT A MINIMUM TO KEEP THE DETECTOR ARRAY SOFTWARE ACTIVE. A REVIEW OF THE SERVICE HISTORY RECORDS FOR THIS DR 9000 SYSTEM WAS COMPLETED AND REVEALED THAT THIS DR 9000 SYSTEM WAS MAINTAINED PER PREVENTIVE MAINTENACE SCHEDULE. KODAK CONTINUES TO INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN IMAGE OF A PT WAS LOST USING THE KODAK DIRECTVIEW DR 9000 SYSTEM DURING A TRAUMA CASE. THE PHYSICIAN REQUESTED THE PT BE IMAGED ON A CT MACHINE, DUE TO PT CONDITION, AFTER THE DR 9000 SYSTEM DID NOT DELIVER THE IMAGE. PT TREATMENT WAS DELAYED UNTIL THE CT SCAN WAS COMPLETE. THE CUSTOMER WAS ABLE TO USE THE KODAK DIRECTVIEW DR 9000 SYSTEM AFTER THE SYSTEM WAS REBOOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KODAK DIRECTVIEW DR 9000 SYSTEM DIAGNOSTIC X-RAY SYSTEM MQB EASTMAN KODAK COMPANY DR 9000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *